Daily Eclipse SPF 30 untinted

Daily Eclipse SPF 30 untinted

Drug Labeling and Warnings

Drug Details

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DAILY ECLIPSE SPF 30 UNTINTED- titanium dioxide, zinc oxide cream 
DermaMed Solutions, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Daily Eclipse SPF 30 untinted

Active ingredients

Titanium Dioxide, 7.5%

Zinc Oxide, 12%

Purpose

Sunscreen

Uses

Helps prevent sunburn

Directions

  • Apply liberally 15 minutes before sun exposure.
  • Children under six months: Ask a doctor.
  • Reapply at least every 2 hours.
  • Use a water resistant sunscreen if swimming or sweating
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 am - 2 pm
  • Wear long-sleeved shirts, pants, hats, and sunglasses

Inactive ingredients

Aqua (water), Capric / Caprylic Triglycerides, Cetearyl Olivate and Sorbitan Olivate, Cimethicone (and) Dimethicone, Glycerin, Cyclopentasiloxane, Aloe Barbadensis, Vaccinium Vitis-idaea Fruit Extract (Lingostern), L- Ascorbic Acid, Camellia Sinensis (Green Tea) Leaf Extract, Phenoxyethanol, Ethylhexylglycerin, Fragrance (Natural)

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

label

DAILY ECLIPSE SPF 30 UNTINTED 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 72492-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE6 g  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.75 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
WATER (UNII: 059QF0KO0R)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
VACCINIUM VITIS-IDAEA FRUIT OIL (UNII: 16Y54799WZ)  
TRICAPRIN (UNII: O1PB8EU98M)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA WHOLE (UNII: KIZ4X2EHYX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 72492-001-0150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/31/2018
2NDC: 72492-001-02118 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/31/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35207/31/2018
Labeler - DermaMed Solutions, LLC (968830559)
Establishment
NameAddressID/FEIBusiness Operations
Trilogy Laboratories, LLC079652958manufacture(72492-001)

Revised: 8/2018
 
DermaMed Solutions, LLC


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